Efficacy of Extended-release Quetiapine (Seroquel XR) as Adjunctive Therapy to Cognitive Behavioral Therapy in the Treat

Mount Sinai Health System

Status

Completed

Conditions

Major Depressive Disorder

Generalized Anxiety Disorder

Treatments

Drug: seroquel xr

Behavioral: CBT

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01971203

GCO 09-0807

Details and patient eligibility

About

The primary objective of the study is to determine whether quetiapine extended-release in combination with cognitive behavioral therapy (CBT) is more effective than CBT plus placebo in treating depressive and anxiety symptoms in patients with both major depression and generalized anxiety disorder. Approximately 64 individuals (adults 18-65) will be randomly assigned to treatment group for 16 weeks. Weekly CBT sessions will be conducted lasting about 45 minutes and weekly visits with the study psychiatrist lasting about 20 minutes in which medication will be discussed. Both clinician administered and self-report measures will be used to compare groups before and after 16 weeks.

Full description

This study will evaluate the efficacy of quetiapine extended-release as adjunctive therapy to cognitive behavioral therapy (CBT) compared to CBT plus placebo in the treatment of patients with comorbid major depression and generalized anxiety disorder. We will also evaluate the quality of life in patients with comorbid MDD/GAD, the response and remission rates by treatment group, changes in sleep quality, and tolerability of adjunctive quetiapine to CBT.

Enrollment

62 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Provision of written informed consent
A diagnosis of both major depression (single episode or recurrent) and generalized anxiety disorder by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV)
Females and/or males aged 18 to 65 years
Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrollment
Able to understand and comply with the requirements of the study

Exclusion criteria

Pregnancy or lactation
Any history of psychosis, bipolar disorder, schizophrenia, eating disorders or OCD
Imminent risk of suicide or a danger to self or others
Known intolerance or lack of response to quetiapine fumarate, as judged by the investigator
Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrollment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir
Use of any of the following cytochrome P450 inducers in the 14 days preceding enrollment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort, and glucocorticoids
Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomization
Substance or alcohol dependence at enrollment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria
Substance abuse by DSM-IV criteria within 6 months prior to enrollment
Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
Unstable or inadequately treated medical illness (e.g. diabetes, angina pectoris, hypertension) as judged by the investigator
Involvement in the planning and conduct of the study
Previous enrollment or randomization of treatment in the present study
Participation in another drug trial within 4 weeks prior to enrollment into this study or longer in accordance with local requirements
A patient with Diabetes Mellitus (DM)